Electrotaxis-conducive stapling

ABSTRACT

Surgical stapling devices have a metal coating on an anvil jaw member of the surgical stapling device, on a surface of staple pockets of a staple cartridge of the surgical stapling device, or any combination thereof. When the surgical stapling device is fired, the metal is transferred from the metal coating on the anvil jaw member, the staple pockets of the staple cartridge, etc., onto the staple. The resulting metal coating on the staple enhances healing of the tissue to which the staple is applied.

TECHNICAL FIELD

The present disclosure relates to medical devices and, moreparticularly, to surgical stapling devices.

BACKGROUND

Surgical stapling instruments are employed by surgeons to sequentiallyor simultaneously apply one or more rows of fasteners, e.g., staples ortwo-part fasteners, to body tissue for the purpose of joining segmentsof the body tissue together. Such instruments generally include a pairof jaws or finger-like structures between which the body tissue to bejoined is placed. When the stapling instrument is actuated, or “fired”,longitudinally moving firing bars contact staple drive members in one ofthe jaws. The staple drive members push the surgical staples through thebody tissue and into an anvil in the opposite jaw, which forms thestaples.

Stapled tissue undergoes a complex wound healing process to restoreflexibility and robustness to the tissue. However, there are instanceswhen wound healing fails, and the patient can develop leaks at the woundsite, including anastomotic leaks. Causes of leaks are frequentlypatient-related, including the quality of tissue being stapled. Forexample, tissue of oncology patients that has been irradiated is verydistinct from healthy tissue, both at the molecular and physiologicallevels, and is more likely to leak.

Improved surgical repair materials, including surgical stapling devicesand staples used therewith, remain desirable.

SUMMARY

Surgical stapling devices which can be used to repair tissue areprovided. In aspects, a surgical stapling device of the disclosureincludes an end effector including an anvil jaw member and a staplecartridge jaw member coupled to one another, the anvil jaw member andthe staple cartridge jaw member being relatively movable such that theend effector is movable between an open position and a clamped position.A metal coating having an anodic potential is on the anvil jaw member.The surgical stapling device also has a staple cartridge having staplepockets in the staple cartridge jaw member and staples in the staplepockets of the staple cartridge, the staples formed of a metal having acathodic potential.

In aspects, the metal coating is formed of magnesium, magnesium alloys,zinc, zinc alloys, or combinations thereof.

In some aspects, the staples are formed of titanium.

In other aspects, the surgical stapling device also includes a secondmetal coating having an anodic potential on at least a portion of asurface of the staple pockets of the staple cartridge. The second metalcoating can be formed of magnesium, magnesium alloys, zinc, zinc alloys,or combinations thereof

In aspects, a surgical stapling device of the disclosure includes an endeffector including an anvil jaw member and a staple cartridge jaw membercoupled to one another, the anvil jaw member and the staple cartridgejaw member being relatively movable such that the end effector ismovable between an open position and a clamped position. A first metalcoating having an anodic potential is on the anvil jaw member. Thesurgical stapling device also has a staple cartridge having staplepockets in the staple cartridge jaw member. A second metal coatinghaving an anodic potential is on at least a portion of a surface of thestaple pockets of the staple cartridge. Staples in the staple pockets ofthe staple cartridge are formed of a metal having a cathodic potential.

In aspects, the first metal coating and the second metal coating areformed of magnesium, magnesium alloys, zinc, zinc alloys, orcombinations thereof.

In other aspects, a surgical stapling device of the disclosure includesan end effector including an anvil jaw member and a staple cartridge jawmember coupled to one another, the anvil jaw member and the staplecartridge jaw member being relatively movable such that the end effectoris movable between an open position and a clamped position. A metalcoating having an anodic potential is on the anvil jaw member. Thesurgical stapling device also has a staple cartridge having staplepockets in the staple cartridge jaw member and staples in the staplepockets of the staple cartridge, and the staples are formed of titanium.

Methods for treating tissue by stapling tissue with the surgicalstapling devices of the disclosure are also provided.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the disclosed surgical stapling device are describedherein below with reference to the drawings, wherein:

FIG. 1 is a perspective view of a surgical stapling device including ahandle, an adapter assembly, and an end effector in accordance with thepresent disclosure;

FIG. 2 is an enlarged view of the indicated area of detail shown in FIG.1 , focusing on an anvil jaw member of the end effector;

FIG. 3 is an enlarged view of the indicated area of detail shown in FIG.1 , focusing on a staple cartridge jaw member of the end effector;

FIG. 4 is an enlarged view of the indicated area of detail shown in FIG.2 ;

FIG. 5 is an enlarged view of the indicated area of detail shown in FIG.3 ;

FIG. 6 is a perspective view of the staple cartridge jaw member of theend effector of the surgical stapling device shown in FIG. 1 , with someparts thereof separated;

FIG. 7 is a perspective view of the end effector of FIG. 1 engaged witha tissue to be stapled;

FIG. 8 is a side cross-sectional view along section line 8-8 of FIG. 7 ,showing the tissue to be stapled between the anvil jaw member and thestaple cartridge jaw member of the end effector;

FIG. 9 is a side cross-sectional view of the end effector of FIG. 1 ,showing formation of staples in the tissue during firing of the surgicalstapling device; and

FIG. 10 is a side view of a staple deployed in tissue in accordance withthe present disclosure.

DETAILED DESCRIPTION

The disclosure provides tissue fixation devices, such as surgicalstapling devices, which deploy staples into tissue to close wounds. Thesurgical stapling device has a coating including a metal with an anodicpotential on portions thereof. The staples are formed of a metal havinga cathodic potential. When the surgical stapling device is fired, legsof the staples come into contact with the metal coating having theanodic potential on the surgical stapling device, thereby transferring aportion of the metal coating from the surgical stapling device onto thelegs of the staples. The deployed staple, formed of a cathodic metal nowpossessing an anodic metal coating on its legs, produces a localdirectional electric field which induces cell migration andproliferation, resulting in accelerated wound healing. Electrotaxis canthus be artificially induced by introducing a charge differential duringthe stapling process, without the need for some additional implant orhaving to compromise the soundness of the anastomosis, and does notrequire any change in surgical techniques.

A variety of surgical stapling devices are encompassed by thedisclosure. In aspects, linear staplers may be utilized such as, forexample, those including EndoGIA™ Reinforced Reload with Tri-StapleTechnology™ and other staplers with Tri-Staple™ technology, availablethrough Covidien, (North Haven, Conn.), as well as other anastomosisstaplers, such as, for example, EEA™, CEEA™, GIA™, EndoGIA™, and TA™,also available through Covidien. It should also be appreciated that theprinciples disclosed herein are equally applicable to surgical staplershaving alternate configurations, such as, for example, end-to-endanastomosis staplers having a circular cartridge and anvil (see, e.g.,commonly owned U.S. Pat. No. 5,915,616, entitled “Surgical FastenerApplying Apparatus”); laparoscopic staplers (see, e.g., commonly ownedU.S. Pat. Nos. 6,330,965 and 6,241,139, each entitled “Surgical StaplingApparatus”); and transverse anastomosis staplers (see, e.g., commonlyowned U.S. Pat. Nos. 5,964,394 and 7,334,717, each entitled “SurgicalFastener Applying Apparatus”).

Aspects of the presently disclosed surgical stapling device will now bedescribed in detail with reference to the drawing figures, wherein likereference numerals identify similar or identical elements. In thefollowing discussion, the terms “proximal” and “trailing” may beemployed interchangeably, and should be understood as referring to theportion of a structure that is closer to a clinician during proper use.The terms “distal” and “leading” may also be employed interchangeably,and should be understood as referring to the portion of a structure thatis further from the clinician during proper use. As used herein, theterm “patient” should be understood as referring to a human subject orother animal, and the term “clinician” should be understood as referringto a doctor, nurse, or other care provider and may include supportpersonnel.

FIGS. 1-6 depict an exemplary surgical stapling device or surgicalstapler 10 for use in stapling tissue. As depicted in FIG. 1 , thesurgical stapling device 10 generally includes a handle 12 and anadapter assembly including an elongate tubular member 14 extendingdistally from the handle 12. An end effector 16 is mounted on a distalend 18 of the elongate tubular member 14. The end effector 16 may bepermanently affixed to the elongate tubular member 14 or may bedetachable and thus replaceable with a new end effector 16.

The end effector 16 includes an anvil jaw member 20 and a staplecartridge jaw member 30 configured to receive a staple cartridge 32(FIGS. 2-3 ). The anvil jaw member 20 is movably mounted on the distalend 18 of the end effector 16 and is movable between an open positionspaced apart from the staple cartridge jaw member 30 to a closedposition substantially adjacent the staple cartridge jaw member 30. Theanvil jaw member 20 has a plurality of staple deforming concavities 22(FIG. 4 ).

The staple cartridge jaw member 30 possesses a staple cartridge 32therein that defines a central knife slot 34 and rows of staple pockets36 on each side of the central knife slot 34 (FIG. 3 ). It is envisionedthat two or more rows of staple pockets 36 can be provided on each sideof the central knife slot 34 (FIGS. 5-6 ). It is also envisioned thatthe staple pockets 36 need not be aligned in rows but rather a varietyof different arrays of staple pockets 36 can be defined on each side ofthe central knife slot 34 (not shown).

As depicted in FIG. 6 , each of the staple pockets 36 receives staples40 and pushers 38. The staples 40 are formed of a suitable metal havinga cathodic potential, such as titanium, titanium alloys, combinationsthereof, and the like.

The surgical stapling device 10 has a metal coating 50 on the anvil jawmember 20 (FIG. 4 ), a metal coating 60 on a surface of the staplepockets 36 of the staple cartridge 32 (FIG. 5 ), or both. Where present,the staple pockets 36 have the metal coating 60 on a surface of thestaple pockets 36 that comes into contact with the staples 40. Suitablemetals for forming the metal coating 50 on the anvil jaw member 20and/or the metal coating 60 on the surface of the staple pockets 36 ofthe staple cartridge 32 include metals having an anodic potential, suchas magnesium, magnesium alloys, zinc, zinc alloys, combinations thereof,and the like.

The metal coating 50 may be applied to the anvil jaw member 20 and/orthe metal coating 60 may be applied to the surface of the staple pockets36 of the staple cartridge 32, in aspects, by applying the metal in asolution, sometimes referred to herein as a “metal solution”, to theanvil jaw member 20 and/or on the surface of the staple pockets 36 ofthe staple cartridge 32.

Any suitable solvent may be used to form the metal solution. Exemplarysolvents encompass pharmaceutically acceptable solvents including, butnot limited to, saline, water, alcohol, acetone, dimethyl sulfoxide,ethyl acetate, N-methylpyrrolidone, combinations thereof, and the like.Methods for forming such solutions are within the purview of thoseskilled in the art and include, but are not limited to, mixing,blending, sonication, heating, combinations thereof, and the like.

The metal solution may be applied to the anvil jaw member 20 and/or thestaple cartridge 32 of the staple cartridge jaw member 30 using anymeans within the purview of those skilled in the art, including dipping,spraying, solution casting, combinations thereof, and the like.

After application, the solvent of the metal solution is driven off sothat the metal coating 50 remains on the anvil jaw member 20 and/or themetal coating 60 remains on the surface of the staple pockets 36 of thestaple cartridge 32. The solvent may be driven off by methods within thepurview of those skilled in the art, including evaporation, heating, theapplication of a vacuum, combinations thereof, and the like. Solventevaporation may be facilitated by heat, gas flow, time, reducedpressure, combinations thereof, and the like.

Driving off the solvent leaves the metal coating 50 on the anvil jawmember 20 and/or the metal coating 60 on the staple cartridge 32 of thestaple cartridge jaw member 30. In some aspects, the metal solution isdeposited in the staple pockets 36 of the staple cartridge 32 of thestaple cartridge jaw member 30 and the solvent is not driven off, so themetal solution remains within the staple pockets 36 (not shown).

In aspects, the entire surface of the staple cartridge 32 may also becoated with a metal as described above (not shown).

As depicted in FIGS. 7-8 , the tissue to be stapled “T” is placedbetween the staple cartridge jaw member 30 and the anvil jaw member 20of the end effector 16 of the surgical stapling device 10. Once thetissue “T” is between the staple cartridge jaw member 30 and the anviljaw member 20 of the end effector 16, the surgical stapling device 10may be fired to deploy staples 40.

Upon firing of the surgical stapling device 10, an actuation sled (notshown) translates through staple cartridge 32 to advance cam wedges (notshown) into sequential contact with the pushers 38, thereby forcing thepushers 38 within the staple cartridge 32 to move vertically (asindicated by arrows “A” in FIG. 9 ), thereby ejecting the staples 40from the staple cartridge 32. Additional details regarding the staplecartridge 32, including mechanisms by which the pushers are advanced todeploy staples from the staple cartridge 32, are described in U.S. Pat.No. 6,241,139.

As depicted in FIG. 9 , as the staples 40 are ejected from the staplecartridge 32, the staple legs 42, 44 pass through the tissue “T”, andcome into contact with the staple deforming concavities 22 of the anviljaw member 20 to deform so that the tissue “T” is sandwiched between thestaple legs 42, 44, thereby securing the adjoining tissue “T” and toseal the tissue “T”.

As the staple legs 42, 44 come into contact with the staple deformingconcavities 22 of the anvil jaw member 20, a portion of the metal fromthe metal coating 50 on the anvil jaw member 20 is transferred to thestaple legs 42, 44, forming a metal coating 70 on the staple legs 42, 44(FIG. 10 ).

Similarly, although not depicted, where the staple pockets 36 of thestaple cartridge 32 have the metal coating 60 thereon or a metalsolution therein, as the staples 40 pass through the staple pockets 38,a portion of the metal coating 60 is transferred onto the staple legs42, 44 forming the metal coating 70 on the staple legs 42, 44.

The difference in metals, i.e. the titanium forming the staple 40 andthe magnesium, magnesium alloys, zinc and/or zinc alloys of the metalcoating 70 on the staple legs 42, 44 forms an electric field. Thiselectric field is depicted by arrows “B” in FIG. 10 , and travels in thedirection from the top (crown) 46 of the staple 40 to the interior “I”of the staple 40. This electric field reduces infection, improvescellular immunity, increases perfusion, and accelerates wound healing.Wound healing is initiated by cell proliferation and migration to therepair site. The directional migration of biological cells is donethrough electric fields, in a process called electrotaxis. The cellsmigrate to the charged are and multiply, thus restoring the health ofthe wound.

The electric field enhances tissue remodeling for tissue within thestaple. The induced electric field provides direction for cells tomigrate and multiply. The metal coating 70 quickly degrades, so theelectric field at the time of repairing the anastomosis will boosthealing immediately and continue through the initial stages of healing.As leaks often occur around day 5 after repair, having this electricfield naturally reinforces the wound using the natural cellularresponse.

It will be understood that various modifications may be made to thedisclosed surgical stapling devices and surgical buttresses. Therefore,the above description should not be construed as limiting, but merely asexemplifications of aspects of the disclosure. Those skilled in the artwill envision other modifications within the scope and spirit of thedisclosure. For example, any and all features of one described aspectmay be suitably incorporated into another aspect.

What is claimed is:
 1. A surgical stapling device, comprising: an endeffector including an anvil jaw member and a staple cartridge jaw membercoupled to one another, the anvil jaw member and the staple cartridgejaw member being relatively movable such that the end effector ismovable between an open position and a clamped position; a metal coatinghaving an anodic potential on the anvil jaw member; a staple cartridgehaving staple pockets in the staple cartridge jaw member; and staples inthe staple pockets of the staple cartridge, the staples formed of ametal having a cathodic potential, wherein in use a portion of the metalcoating on the anvil jaw member is transferred to legs of the staple,thereby forming an electric field between a crown of the staple and thelegs of the staple.
 2. The surgical stapling device of claim 1, whereinthe metal coating is formed of magnesium, magnesium alloys, zinc, zincalloys, or combinations thereof.
 3. The surgical stapling device ofclaim 1, wherein the staples are formed of titanium.
 4. The surgicalstapling device of claim 1, further comprising a second metal coatinghaving an anodic potential on at least a portion of a surface of thestaple pockets of the staple cartridge.
 5. The surgical stapling deviceof claim 4, wherein the second metal coating is formed of magnesium,magnesium alloys, zinc, zinc alloys, or combinations thereof.
 6. Amethod for treating tissue comprising stapling tissue with the surgicalstapling device of claim
 1. 7. A surgical stapling device, comprising:an end effector including an anvil jaw member and a staple cartridge jawmember coupled to one another, the anvil jaw member and the staplecartridge jaw member being relatively movable such that the end effectoris movable between an open position and a clamped position; a firstmetal coating having an anodic potential on the anvil jaw member; astaple cartridge having staple pockets in the staple cartridge jawmember; a second metal coating having an anodic potential on at least aportion of a surface of the staple pockets of the staple cartridge; andstaples in the staple pockets of the staple cartridge, the staplesformed of a metal having a cathodic potential, wherein in use a portionof the first metal coating on the anvil jaw member or a portion of thesecond metal coating on at least a portion of the surface of the staplepockets is transferred to legs of the staple, thereby forming anelectric field between a crown of the staple and the legs of the staple.8. The surgical stapling device of claim 7, wherein the first metalcoating is formed of magnesium, magnesium alloys, zinc, zinc alloys, orcombinations thereof.
 9. The surgical stapling device of claim 7,wherein the second metal coating is formed of magnesium, magnesiumalloys, zinc, zinc alloys, or combinations thereof.
 10. The surgicalstapling device of claim 7, wherein the staples are formed of titanium.11. A method for treating tissue comprising stapling tissue with thesurgical stapling device of claim
 7. 12. A surgical stapling device,comprising: an end effector including an anvil jaw member and a staplecartridge jaw member coupled to one another, the anvil jaw member andthe staple cartridge jaw member being relatively movable such that theend effector is movable between an open position and a clamped position;a metal coating having an anodic potential on the anvil jaw member; astaple cartridge having staple pockets in the staple cartridge jawmember; and staples formed of titanium in the staple pockets of thestaple cartridge, wherein in use a portion of the metal coating on theanvil jaw member is transferred to legs of the staple, thereby formingan electric field between a crown of the staple and the legs of thestaple.
 13. The surgical stapling device of claim 12, wherein the metalcoating is formed of magnesium, magnesium alloys, zinc, zinc alloys, orcombinations thereof.
 14. The surgical stapling device of claim 12,further comprising a second metal coating having an anodic potential onat least a portion of a surface of the staple pockets of the staplecartridge.
 15. The surgical stapling device of claim 14, wherein thesecond metal coating is formed of magnesium, magnesium alloys, zinc,zinc alloys, or combinations thereof.
 16. A method for treating tissuecomprising stapling tissue with the surgical stapling device of claim12.